Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Glasgow.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00204126
First received: September 12, 2005
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

Treadmill therapy has the potential to improve the physical fitness and voluntary function of incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a rehabilitation strategy, evidence must be gathered to support its effectiveness. Present methods used to determine the efficacy of treadmill training do not provide accurate means of monitoring changes in physical fitness during the exercise, or to accurately measure the changes in voluntary muscle function which may occur during a training intervention.

We are therefore currently recruiting subjects for a study investigating the feasibility of new methods for monitoring improvements in physical fitness during walking on a treadmill. We also aim to develop methods for monitoring changes in voluntary muscle strength. The bone density of both legs will also be measured to determine if any improvement has occurred following training.


Condition Intervention
Spinal Cord Injury
Device: Treadmill with partial body weight support
Device: Surface Functional Electrical Stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Determination of Novel Methods of Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • peak oxygen uptake
  • lactate threshold
  • oxygen uptake kinetics

Secondary Outcome Measures:
  • torque during maximum voluntary contractions in leg muscles
  • central activation ratio of leg muscles
  • bone mineral density in tibia and femur

Estimated Enrollment: 4
Study Start Date: February 2005
Estimated Study Completion Date: February 2005
Detailed Description:

Treadmill therapy has the potential to improve the cardiopulmonary fitness, voluntary function, and lower limb bone density of incomplete spinal cord injury (SCI) patients. However, if it is to be offered clinically as a rehabilitation strategy then evidence must be gathered to support its effectiveness.

The efficacy of FES−assisted walking with incomplete SCI individuals, both overground and on a treadmill, has previously been assessed by monitoring walking speed, stride length, endurance, cadence, the physiological and oxygen cost, % body weight support (treadmill), and by performing observational gait analysis and manual muscle testing (1,2,3,4,5,6). However, these methods do not provide a means of measuring changes in fitness or for accurately monitoring improvements in voluntary muscle function.

At present appropriate methods for testing a person's cardiopulmonary fitness on a treadmill are lacking. Previously, incremental exercise tests have been carried out by maintaining a constant inclination and increasing the speed linearly.

However, if the speed is increased linearly it is likely that it will increase at too fast a pace. Therefore the test will become a measure of the subject's ability to move their legs quickly and/or efficiently enough, rather than metabolic factors. If a steep gradient is chosen as the constant inclination then a high initial metabolic cost will result, which will limit the test time. Another common method used is to maintain a constant speed while increasing the sine of the angle of inclination. The problem with this method of testing is that if too low a speed is selected then a very steep gradient results before the level of tolerance is reached, and if too high a speed is selected there is a high initial metabolic cost. These problems were addressed in a recent paper by Porszasz et al., 2003 (7). They demonstrated that by increasing walking speed linearly and treadmill gradient curvilinearly, a linear increase in work rate occurs with the subjects fatiguing at a moderate speed. If this protocol could be adapted for use with incomplete SCI patients it would provide an accurate means of testing changes in cardiopulmonary function which may result after treadmill training.

It has recently been recorded that dynamometry (rather than manual muscle scores) should be used to assess changes in voluntary function in incomplete SCI patients (8). Therefore we will employ this approach in this study. Following a spinal injury there is a rapid decline in bone mineral density which increases the risk of fracture following minor trauma. Therefore we will also measure the bone density at the epiphyses and shaft of the tibia and femur to determine if this form of training leads to changes in bone mineral density in this patient population.

By demonstrating that treadmill training can improve the cardiopulmonary fitness of individuals with incomplete SCI, their voluntary strength, and bone mineral density, it will help to provide the evidence that this form of rehabilitation is worthwhile.

By increasing cardiopulmonary fitness it will reduce their risk of developing cardiovascular disease, a major problem in this population due to their sedentary lifestyle. If it can be demonstrated to improve their voluntary function it would suggest that their quality of life and ability to carry out activities of daily living may also improve. Improving their bone density would consequently reduce their risk of fracture. Therefore the results of this study will contribute to the quest of trying to improve the overall health and functional ability of this patient population.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Satisfactory general medical examination
  • Incomplete paraplegia or tetraplegia secondary to spinal cord lesion
  • Previously discharged from hospital, following primary rehabilitation
  • Capable of independent ambulation, with or without orthotic support

Exclusion Criteria:

  • Female subjects should not be pregnant.
  • No significant history of autonomic dysreflexia.
  • No history of significant osteoporosis, or associated previous history of spontaneous lower−limb fracture. Bone density will be measured in the epiphyses of the tibia and femur of both legs using peripheral Quantitative Computed Tomography (pQCT).
  • No history of coronary heart disease.
  • No clinical features of significant cardio−respiratory impairment.
  • Absence of hypertension.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204126

Locations
United Kingdom
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Lanarkshire, United Kingdom, G51 4TF
University of Glasgow
Glasgow, Lanarkshire, United Kingdom, G12 8QQ
Sponsors and Collaborators
University of Glasgow
Investigators
Principal Investigator: Kenneth J Hunt, BSc, PhD, DSc University of Glasgow
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00204126     History of Changes
Other Study ID Numbers: GUTreadmillSCI
Study First Received: September 12, 2005
Last Updated: September 8, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:
exercise testing
treadmill
incomplete spinal cord injury
novel methods

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014